America’s Blood Centers (ABC), the Association for the Advancement of Blood & Biotherapies (AABB), the American Red Cross, and Blood Centers of America (BCA) sent a joint letter to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) this week outlining supply chain challenges facing blood centers, and both ongoing and potential future remedies to promote “long-term stability of the blood supply chain.” In the March 1st letter, the blood community thanked CBER for collaboration, “open discussions and sharing of information” that impacts the nation’s blood collectors throughout the pandemic.
The organizations suggest collaborative solutions to prevent future supply chain challenges in the form of:
- “[e]xpedited FDA Licensure of the Fresenius Kabi Hořátev site: Emergency Use Authorization (EUA) is currently set to expire in December 2023. To avoid blood centers having to validate another bag option and hospitals having to ready for yet another new bag, we request licensure occur as soon as possible;
- [e]xpedite FDA evaluation and licensure of apheresis kits and solutions to meet critical supply shortfalls to ensure clinical needs for platelets can be met;
- [a]llowing solutions already in use in Europe a faster path for FDA approval in the U.S. (e.g., buffy coats);
- [e]nsured capacity and business continuity for key suppliers in the blood industry; [and]
- [s]trategic reserves of key supplies supported by the federal government.”
Additionally, the blood community also lists measures taken by blood centers to offset supply chain challenges in the letter while describing the staff time required and the incremental costs associated in undertaking such steps as:
- “[v]alidating additional bags, including the Fresenius Kabi CompoSelect bag manufactured in Hořátev, Czech Republic and currently approved under an EUA. To date, we have moved more than two million collections to this bag, with additional transitions planned;
- [a]djusting manufacturing operations to accommodate collection set changes;
- [m]odifying recruitment and collections activities based on the available supplies; and
- [i]ncreased recruitment efforts to grow whole blood donations to supplement the lack of double red cell procedures (due to limited kit availability) or depending upon the blood center the reverse.”
The letter closes by reiterating the blood community’s willingness to continue collaborating with CBER to meet the needs of all patients requiring blood and blood components.